Alendronic Acid 70 Mg Tablets
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ALENDRONIC ACID 70 MG TABLETS
(alendronate monosodium trihydrate)
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you..
• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours..
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4..
What is in this leaflet:
1. What Alendronic Acid 70 mg Tablets are and what they are used for
2. What you need to know before you take Alendronic Acid 70 mg Tablets
3. How to take Alendronic Acid 70 mg Tablets
4. Possible side effects
5. How to store Alendronic Acid 70 mg Tablets
6. Contents of the pack and other Information
1. WHAT ALENDRONIC ACID 70 MG TABLETS ARE AND WHAT THEY ARE USED FOR What is Alendronic Acid 70 mg Tablets?
Alendronic Acid 70 mg Tablets contain a medicine called alendronate.It belongs to a group of medicines called “bisphosphonates”. Alendronic Acid 70 mg Tablets prevents the loss of bone that occurs in women after they have been through the menopause It can also prevent loss of bone in men or people taking steroids, such as prednisolone and methylprednisolone.
It has also been shown to help rebuild bone and reduce the risk of spine and hip fractures (broken bones) in women (after their menopause) and in men who have thinning of their bones (osteoporosis). What is Alendronic Acid 70 mg Tablets used for?
Your doctor has prescribed Alendronic Acid 70 mg Tablets because you either have osteoporosis or you are at risk of developing this disease.
What is osteoporosis?
Osteoporosis is thinning and weakening of your bones. It is common in women after the menopause. At the menopause, the ovaries stop producing the female hormone, oestrogen, which helps to keep a woman’s skeleton healthy. As a result, bone loss occurs and bones become weaker. The earlier a woman reaches the menopause, the greater the risk of osteoporosis.
Osteoporosis can also occur in men due to a number of causes including ageing and/or a low level of the male hormone, testosterone. In all instances, bone is removed faster than it is formed, so bone loss occurs and bones become weaker.
Corticosteroids can also cause bone loss and osteoporosis in both men and women.
Early on, osteoporosis usually has no symptoms. If left untreated it can result in broken bones. Although these usually hurt, breaks in the bones of the spine may go unnoticed until they cause height loss. Broken bones can happen during normal, everyday activity, such as lifting, or from minor injuries that would not fracture normal bone. Broken bones usually occur at the hip, spine, or wrist and can lead not only to pain but also considerable problems like stooped posture (‘dowager’s hump’) and loss of mobility.
How can osteoporosis be treated or prevented?
It is important to remember that if you already have osteoporosis that it can be treated and that it is never too late to begin. Alendronic Acid 70 mg Tablets not only prevents the loss of bone but actually helps to rebuild bone you may have lost and reduces the risk of bones breaking in the spine and hip.
In addition to your treatment with Alendronic Acid 70 mg Tablets, your doctor may recommend that you make some changes to your lifestyle which may help your condition. These are:
Stopping smoking Smoking appears to increase the rate at which you lose bone and therefore, may
increase your risk of broken bones.
Exercise Like muscles, bones need exercise to stay strong and healthy. Talk to your
doctor before you begin any exercise programme.
Eating a balanced diet Your doctor can advise you about your diet or whether you should take any dietary supplements (especially calcium and vitamin D)
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ALENDRONIC ACID 70 MG TABLETS Do not take Alendronic Acid 70 mg Tablets if you:
• are allergic (hypersensitive) to alendronate monosodium trihydrate or any of the other ingredients of Alendronic Acid 70 mg Tablets (listed in section 6).
• have certain problems with your gullet (oesophagus - the tube that connects your mouth with your stomach) such as narrowing or difficulty swallowing.
• cannot stand or sit upright for at least 30 minutes.
• If your doctor has told you that you have low blood calcium.
If you think any of these apply to you, do not take the tablets. Talk to your doctor or pharmacist first and follow the advice given.
Warnings and precautions:
Talk to your doctor or pharmacist before taking Alendronic Acid 70 mg Tablets if you:
• suffer from kidney problems
• have any swallowing or digestive problems
• your doctor has told you that you have Barrett’s oesophagus (a condition associated with changes in the cells that line the lower oesophagus)
• have been told you have low blood calcium
• have poor dental health, gum disease, a planned dental extraction or you don’t receive routine dental care
• have cancer
• are undergoing chemotherapy or radiotherapy,
• are taking corticosteroids (such as prednisone or dexamethasone),
• are or have been a smoker (as this may increase the risk of dental problems).
You may be advised to have a dental check-up before starting treatment with Alendronic Acid 70 mg Tablets.
It is important to maintain good oral hygiene when being treated with Alendronic Acid 70 mg Tablets. You should have routine dental check-ups throughout your treatment and you should contact your doctor or dentist if you experience any problems with your mouth or teeth such as loose teeth, pain or swelling.
Irritation, inflammation or ulceration of the gullet (oesophagus - the tube that connects your mouth with your stomach) often with symptoms of chest pain, heartburn, or difficulty or pain upon swallowing may occur, especially if patients do not drink a full glass of water and/or if they lie down less than 30 minutes after taking Alendronic Acid 70 mg Tablets . These side effects may worsen if patients continue to take Alendronic Acid 70 mg Tablets after developing these symptoms.
Children and adolescents:
Alendronic Acid 70 mg Tablets is not indicated for use in children and adolescents.
Other medicines and Alendronic Acid 70 mg Tablets:
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
It is likely that calcium supplements, antacids, and some oral medicines will interfere with the absorption of Alendronic Acid 70 mg Tablets if taken at the same time. Therefore, it is important that you follow the advice given in section 3, How to take Alendronic Acid 70 mg Tablets.
Certain medicines for rheumatism or long-term pain called NSAIDs (e.g. aspirin or ibuprofen) might cause digestive problems. Therefore, caution should be used when these medicines are taken at the same time as Alendronic Acid 70 mg Tablets.
Alendronic Acid 70 mg Tablets with food and drink:
It is likely that food and drinks (including mineral water) will make Alendronic Acid 70 mg Tablets less effective if taken at the same time. Therefore it is important that you follow the advice given in Section 3, How to take Alendronic Acid 70 mg Tablets..
Pregnancy and breast-feeding:
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Alendronic Acid 70 mg Tablets is only intended for use in postmenopausal women. Do not take Alendronic Acid 70 mg Tablets if you are or think you may be pregnant, or if you are breast-feeding..
Driving and using machines:
There have been side effects (including blurred vision, dizziness and severe bone, muscle or joint pain) reported with Alendronic Acid 70 mg Tablets that may affect your ability to drive or operate machinery. Individual responses to Alendronic Acid 70 mg Tablets may vary (See Possible Side Effects.).
3. HOW TO TAKE ALENDRONIC ACID 70 MG TABLETS
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Taking your medicine
It is very important that you follow actions 1 to 5 to help the tablet reach your stomach quickly and help reduce possible irritation of your oesophagus (the tube that connects your mouth with your stomach).
1. After getting up for the day, and before taking any food, drink or other medicine, swallow your Alendronic Acid 70 mg Tablets whole with a full glass of plain water only (not less than 200 ml or 7 fl. oz.)
• Do not take with mineral water (still or sparkling)
• Do not take with coffee or tea
• Do not take with juice or milk.
• Do not crush or chew the tablet or allow it to dissolve in your mouth.
2. Do not lie down, stay fully upright (sitting, standing or walking) for at least 30 minutes after swallowing the tablet. Do not lie down until after your first food of the day.
3. Do not take Alendronic Acid 70 mg Tablets at bedtime or before getting up for the day.
4. If you develop difficulty or pain upon swallowing, chest pain, or new or worsening heartburn, stop taking Alendronic Acid 70 mg Tablets and talk to your doctor immediately.
5. After swallowing your tablet, wait at least 30 minutes before taking your first food, drink, or other medicine of the day, including antacids, calcium supplements and vitamins. Alendronic Acid 70 mg Tablets will only work if your stomach is empty.
You must take Alendronic Acid 70 mg Tablets exactly as your doctor has told you. It is important that you continue taking Alendronic Acid 70 mg Tablets for as long as your doctor prescribes the medicine.
The recommended dosage is
• for the treatment of osteoporosis in men and post-menopausal women the usual dose is 10 mg once a day.
• for the treatment and prevention of steroid induced osteoporosis in post-menopausal women not receiving hormone replacement therapy (HRT) with an oestrogen the usual dose is 10 mg once a day.
If you take more Alendronic Acid 70 mg Tablets than you should:
If you take too many Alendronic Acid 70 mg Tablets by mistake, drink a full glass of milk and contact your doctor immediately. Do not make yourself vomit, and do not lie down.
If you forget to take Alendronic Acid 70 mg Tablets:
• If you forget to take your dose, skip the missed dose.
• Take the next dose as normal.
• Do not take a double dose to make up for a forgottendose.
If you stop taking Alendronic Acid 70 mg Tablets:
It is important that you continue taking Alendronic Acid 70 mg Tablets for as long as your doctor prescribes the medicine for you. Alendronic Acid 70 mg Tablets can treat your osteoporosis only if you continue to take the tablets.
If you have any further questions on the use of this medicine ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them. .
If the following happens, stop taking the tablets and tell your doctor immediately or go to the accident and emergency department at your nearest hospital:
- An allergic reaction (angioedema): swelling of the face, lips, tongue or throat, or difficulty breathing or swallowing.
This is a very serious but rare side effect (may affect up to 1 in 1000 people). You may need urgent medical attention or hospitalisation.
Other side effects
Very Common (may affect more than 1 in 10 people):
• bone, muscle and/or joint pain which is sometimes severe.
Common (may affect up to 1 in 10 people):
• heartburn; difficulty swallowing; pain upon swallowing, ulceration of the gullet (oesophagus - the tube that connects your mouth with your stomach) which can cause chest pain, heartburn or difficulty or pain upon swallowing
• joint swelling
• abdominal pain; uncomfortable feeling in the stomach or belching after eating; constipation; full or bloated feeling in the stomach; diarrhoea; flatulence;
• hair loss, itching
• headache, dizziness
• tiredness, swelling in the hands or legs.
Uncommon (may affect up to 1 in 100 people):
• nausea, vomiting
• irritation or inflammation of the gullet (oesophagus - the tube that connects your mouth with your stomach) or stomach
• black or tar-like stools
• blurred vision, pain, inflammation or redness in the eye
• rash, reddening of the skin, itching
• transient flulike symptoms such as aching muscles, generally feeling unwell and sometimes fever usually at the start of treatment
• taste disturbance.
Rare (may affect up to 1 in 1000 people):
• allergic reactions such as hives; swelling of the face, lips, tongue and/or throat, possibly causing difficulty breathing or swallowing. Stop taking this medicine and contact your doctor right away if you experience such symptoms;
• symptoms of low blood calcium levels including muscle cramps or spasms and/or tingling sensation in the fingers or around the mouth
• stomach or peptic ulcers (sometimes severe or with bleeding)
• narrowing of the gullet (oesophagus - the tube that connects your mouth with your stomach)
• rash made worse by sunlight;
• severe reactions involving your skin, mucous membranes of your mouth, nose eyes or genitals. Stop taking this medicine and contact your doctor right away if you experience such symptoms;
• pain in the mouth, and/or jaw, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw, or loosening of a tooth. These could be signs of bone damage in the jaw (osteonecrosis) generally associated with delayed healing and infection, often following tooth extraction. Contact your doctor and dentist if you experience such symptoms
• unusual fracture of the thigh bone particularly in patients on long-term treatment for osteoporosis may occur rarely. Contact your doctor if you experience pain, weakness or discomfort in your thigh, hip or groin as this may be an early indication of a possible fracture of the thigh bone.
• Mouth ulcers when the tablets have been chewed or sucked.
Tell your doctor or pharmacist promptly about these or any other unusual symptoms.
It will help if you make a note of what you experienced, when it started and how long it lasted.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE ALENDRONIC ACID 70 MG TABLETS
Keep this medicine out of the sight and reach of children.
Do not use Alendronic Acid 70 mg Tablets after the expiry date which is stated on the outer packaging. The expiry date refers to the last day of the month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
This medicine does not require any special storage conditions.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Alendronic Acid 70 mg Tablets contains
- The active substance is alendronate monosodium trihydrate and each tablet contains 70 mg alendronic acid as alendronate monosodium trihyderate.
- The other ingredients are microcrystalline cellulose, crospovidone and magnesium stearate.
What Alendronic Acid 70 mg Tablets look like and contents of the pack
Each tablet is white, oval, flat and marked with a “70” on one side.
Alendronic Acid 70 mg Tablets are available in blisters of 2, 4, 8, 12 & 40 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: TEVA UK Limited, Eastbourne, BN22 9AG.
Manufacturer: Teva Pharma S.L.U, Poligono Industrial Malpica, calle C, 50016 - Zaragoza, Spain.
This leaflet was last approved in 01/2015.
PL 00289/1956